לוח אפשרויות קריירה - הדרך החכמה להייטק

The opportunity
Regulatory Affairs associate I – RA publishing will participate in the publishing of different regulatory activities.  The focus will be to ensure 100% quality and timeline of the submission. This role will be the primary interface with the Regulatory Affairs Associate
How you’ll spend your day
Publish and dispatch major and complex routine/lifecycle management eCTD submission projects      for EU, US and Canada.
Exposure in handling post approval submissions publishing and transmitting quality submissions to   agency.
Perform document level publishing activities, troubleshoot document issues and perform quality control checks for submission ready documents as per the agency guidance.
Collaborate with scientific personnel for planning, preparation and publishing.
Maintain working knowledge of internal and external publishing standards.
Basic knowledge of ICH and eCTD related specification/guidelines governing regulatory submissions (eCTD, NeeS, paper)
Must be aware of Technical systems like Global Insight, Veeva Vault, ISI Toolbox, Adobe Acrobat, Lorenz Validator